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Checklists and Bundles: Patient Safety Tools Require Appropriate Implementation

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By Kelly M. Pyrek

Evidence-based practice is being implemented through a variety of patient-safety tools, but perhaps checklists and bundles remain one of the best ways to drive down infection rates and boost compliance among healthcare personnel that leads to better patient outcomes. Atul Gawande, MD, in his book The Checklist Manifesto, analyzes the positive impact of checklists in healthcare and in other industries, to handle “the volume and complexity of what we know.” As Gawande (2010) explains, "Know-how and sophistication have increased remarkably across almost all our realms of endeavor, and as a result so has our struggle to deliver on them … Avoidable failures are common and persistent, not to mention demoralizing and frustrating, across many fields—from medicine to finance, business to government. And the reason is increasingly evident: the volume and complexity of what we know has exceeded our individual ability to deliver its benefits correctly, safely, or reliably. Knowledge has both saved us and burdened us."

The Agency for Healthcare Research and Quality (AHRQ) defines a checklist as an algorithmic listing of actions to be performed in a given clinical setting, the goal being to ensure that no step will be forgotten. The agency adds that "Although a seemingly simple intervention, check-lists have a sound theoretical basis in principles of human factors engineering and have played a major role in some of the most significant successes achieved in the patient safety movement."
AHRQ acknowledges that many tasks are performed reflexively or "on autopilot," and that the types of error associated with various behaviors are different: "Failures of schematic behavior are called slips and occur due to lapses in concentration, distractions, or fatigue, whereas failures of attentional behavior are termed mistakes and often are caused by lack of experience or insufficient training. In healthcare, as in other industries, most errors are caused by slips rather than mistakes, and checklists represent a simple, elegant method to reduce the risk of slips. Flight preparation in aviation is a well-known example, as pilots and air-traffic controllers follow pre-takeoff checklists regardless of how many times they have carried out the tasks involved. By standardizing the list of steps to be followed, and formalizing the expectation that every step will be followed for every patient, checklists have the potential to greatly reduce errors due to slips."

In their review, Hales, et al. (2008) identified several types of checklists:
- Laundry list: Items, tasks or criteria are grouped into related categories with no particular order. An example would be a medical equipment checklist 
- Sequential or weakly sequential checklist: The grouping, order and overall flow of the items, tasks or criteria are relevant in order to obtain a valid outcome. An example would be a procedure checklist (equipment must be gathered before procedure can begin)
- Iterative checklist: Items, tasks or criteria on the checklist require repeated passes or review in order to obtain valid results, as early check-points may be altered by results entered in later checkpoints
- Diagnostic checklist: Items, tasks or criteria on the checklist are formatted based on a ‘flowchart’ model with the ultimate goal of drawing broad conclusions. An example would be clinical algorithms.
- Criteria of merit checklist: Commonly used for evaluative purposes, in which the order, categorization and flow of information is paramount for the objectivity and reliability of the conclusions drawn
Hales, et al. (2008) also recommend that checklist designers should understand the conditions under which the clinician would be referring to or completing the checklist in order to determine the appropriate content and flow; the following should be taken into consideration:
- Ensuring that the time required to complete the revised checklist is feasible, practical and does not interfere with time-to-delivery of appropriate and safe patient care
- Ensuring that the checklists pass through appropriate administrative or regulatory authorities
- Provide clinicians with freedom to use their clinical judgment
- Checklists should be reviewed frequently to reflect updates in the evidence-based medicine, published guidelines and institutional policies and procedures

They emphasize that checklists are an entity that should evolve with an institution's needs and imperatives: " Legitimacy of the content will depend on the process for its development, and should include a thorough review and evaluation of the literature, evaluation of current practices and consideration of expert consensus, as well as a thorough validation of the checklist in the target user population prior to implementation of the final document. Checklist development should not be static, but an ongoing process involving expert groups, up-to-date literature, and feedback from the intended users as well as the target audience. When all staff members that might interact with the checklist have been involved in the process of creating and designing the checklist, there is a feeling of ownership of the checklist. The items contained in the final checklist represent a consensus between all members of the team, and improve implementation and uptake of a checklist into daily practice." 

The American Hospital Association and the Health Research & Educational Trust (2013) observe that "Checklists used in the medical setting can promote process improvement and increase patient safety. Implementing a formalized process reduces errors caused by lack of information and inconsistent procedures. Checklists have improved processes for hospital discharges and patient transfers as well as for patient care in intensive care and trauma units. Along with improving patient safety, checklists create a greater sense of confidence that the process is completed accurately and thoroughly." 

Sue Hohenthaner, the enterprise infection prevention director, PPS hospitals and clinics for Dakotas-based Sanford Health, says that check-lists and bundles are very effective tools based on reliability science. "Both have been proven in many high-reliability/high risk industries outside of medicine such as nuclear power and the defense industry – and are crucial to basic standardization efforts as relating to the daily care of patients," she says. "Checklists such as the 'time out' prior to any surgical procedure - enable processes of patient care to have the right people and the right materials available every time, in every place and with every patient encounter. They are therefore foundational to process improvement and promote and increase overall quality at the bottom of which is patient safety.  The surgical time out has been proven conclusively and internationally to reduce mortality and morbidity in surgical patients. Bundles in conjunction with the checklist capture all elements that should occur every time and so mitigate errors caused by our human factors dense industry. Checklists and bundles are therefore routinely a part of best practice/evidence-based healthcare delivery – because we are humans caring for humans."

Hohenthaner says that bundles and checklists are used for central line/Foley catheter placement and ongoing care as well as ventilator management in her facility. "The goal of both is to promote compliance with best practices," she says. "When an infection is identified, a group of unit leadership, direct care givers, infection preventionists and quality improvement staff meet and utilize a defect tool (mini RCA) to help identify opportunities for improvement such as gaps in communication, reliability of processes, and education. Always a part of these efforts is to look at compliance with the bundles that are in place (CLABSI, CAUTI and VAP). Currently, we are able to run reports from the defect tools for CLABSI and CAUTI. This assists in looking at common themes and/or trends. Checklists are also routinely used for competencies for nurses and other healthcare staff members. Some examples of competencies that are used include Trophon, high-level disinfection, accessing and de-accessing central lines and insertion of Foley catheters." 

To attain the best possible results, Hohenthaner advises institutions to "Engage staff and leadership, and make it a priority.  Share success stories both internal and external. Be transparent about adverse events and how these tools can be maximized. Look to organizations that have been successful in implementing checklists and bundles and seek to replicate what they have implemented."

Critics of checklists claim they encourage healthcare personnel to merely check boxes on technical elements while ignoring "socio-adaptive" elements. As Bosk, et al. (2009) explain their concerns, "Safer care is achieved when all three—not just one—of the following are realized: summarize and simplify what to do; measure and provide feedback on outcomes; and improve culture by building expectations of performance standards into work processes. We propose that widespread deployment of checklists without an appreciation of how or why they work is a potential threat to patients' safety and to high-quality care."
Chopra and Shojania (2013) emphasize that technical elements of checklists and bundles -- such as the use of chlorhexidine for skin antisepsis -- "comprise discrete, easily implemented actions. Socio-adaptive elements (e.g., removal of unnecessary CVCs, or the preoperative time-out to discuss critical steps in a surgical plan) involve more than simple actions: they require true engagement in the tasks. Implementation efforts must, therefore, address teamwork, communication and culture."

Bosk, et al. (2009) concur and note, "To improve safety, healthcare needs to get the technical and adaptive work right. Without attention to adaptive work, checklists would probably suffer the same fate as guidelines—often left unused, even when very robust. Summarizing evidence is a necessary but not sufficient step for translating evidence into practice. Evidence summaries need to be combined with an under-standing of, and a strategy for, mitigating the technical and social/political and psychological (even emotional) barriers to using the evidence, and with feedback about performance. Emphasizing checklists as the explanatory mechanism for the reduction in catheter-related infections obscures the complex labor necessary to create a collective local faith in checklists."

In what was to become one of the most-cited studies on the benefits of patient-safety-tools, Berenholtz and Pronovost, et al. (2004) de-signed a quality improvement model for central line-associated infections (CLABSI) that featured a checklist and a bundle of evidence-based practices, which included proper hand hygiene, chlorhexidine for skin antisepsis, use of maximal sterile barriers, and avoidance of the femoral site. The bundle was accompanied by the provision of education regarding these infection control practices, a catheter-insertion cart, daily re-view and prompt removal of unwarranted CVCs and empowerment of nurses to enforce adherence to these practices.

Chopra and Shojania (2013) point to several evaluations of this bundled intervention; the first revealed a decrease in CVC-BSIs from 11.3 infections/1,000 catheter days to 0/1,000 catheter days at Johns Hopkins; a second evaluation of the CVC-BSI bundle in 103 intensive care units (ICUs) across 77 hospitals by the Michigan Keystone Health and Hospital Association showed a large and statistically significant reduction in CVC-BSIs -- from a baseline mean of 7.7 infections/1,000 catheter days to 1.4/1,000 catheter days.  As Chopra and Shojania (2013) note, "The success of the CVC-BSI bundle stimulated interest in checklists for surgical safety. WHO’s Surgical Safety Checklist led to substantial improvements in operative outcomes in diverse clinical settings. A study of multiple checklists at different stages in the perioperative period showed impressive improvements in surgical complications and mortality at six hospitals in The Netherlands. These dramatic results—in ICUs and operating rooms— made checklists virtually synonymous with safer innovative care."

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